Foot Ulcer, DiabeticILHNCT01580917
Dynamic Plantar Microvascular Skin Response to Compressive Loads in At-risk Diabetic and Healthy Control: a Pilot Study
An observational study of Foot Ulcer, Diabetic, run by Temple University at 1 site in United States.
Trial summary
The purpose of this pilot study is to compare the dynamic response of microcirculation in the skin on the bottom of the big toe after applying controlled plantar stress in 25 diabetic subjects with a history of foot ulcer and 25 age-matched healthy controls to better understand the role of local hypoxia in neuropathic… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Foot Ulcer, Diabetic
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A community sample
Who may be able to join
- between ages 40 and 75
- history of diabetic neuropathic plantar ulcer (test subjects)
- no history of diabetes (control subjects)
- no peripheral sensory neuropathy (control subjects)
Who cannot join
- amputation or surgery on right Great Toe
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University School of Podiatric Medicine Gait Study Center
Philadelphia, Pennsylvania, 19107
About this study
Official title: Dynamic Plantar Microvascular Skin Response to Compressive Loads in At-risk Diabetic and Healthy Control
The purpose of this pilot study is to compare the dynamic response of microcirculation in the skin on the bottom of the big toe after applying controlled plantar stress in 25 diabetic subjects with a history of foot ulcer and 25 age-matched healthy controls to better understand the role of local hypoxia in neuropathic foot ulceration in subjects with diabetes.
The investigators hypothesize that if they apply a gait simulating load to the plantar foot and measure microvascular function, diabetic individuals will demonstrate an increased delay in reestablishing microvascular flow compared to healthy individuals.
- Conditions
- Foot Ulcer, Diabetic
- Keywords
- laser doppler anemometry, dynamic testing of tissue mechanical property, diabetic foot complications, ulcer genesis
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Test | Diabetic individuals with a history of previous plantar ulcer and a high risk of developing a foot ulceration | |
| Healthy Controls | Non-diabetic, healthy individuals with low risk of developing a neurogenic foot ulcer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency time after occlusive loading
The time between removal of occluding pressure and the initiation of the post-occlusive hyperemic response as measured by laser Doppler.
Measured: approximately 2.75 minutes after start of collection protocol
Secondary outcomes (2)
Response time to baseline
The time interval between the start of post-occlusive hyperemic response and when the response curve reaches the baseline, or reference, flow level as measured by laser doppler.
Measured: 2.75 seconds after start of collection protocol
Response time to Maximum Flow
The time interval between the start of the post-occlusive hyperemic response and the time to reach maximum flow as measured by laser doppler
Measured: At least 2.75 seconds after the start of collection protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startNov 2007
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcer, DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinsup Song, DPM, PhD, Study director, Temple UniversityJames A Furmato, DPM, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580917
- Sponsor's protocol ID
- TUSPM-JF-01
- Acronym
- ILH
- Status last verified
- Dec 2016
- First submitted
- 17 Apr 2012
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Plantar Microvascular Skin Response to Compressive Loads in At-risk Diabetic and Healthy Control
- ClinicalTrials.gov ID
- NCT01580917
- Acronym / sponsor ID
- ILH / TUSPM-JF-01
- Conditions
- Foot Ulcer, Diabetic
- Keywords
- laser doppler anemometry, dynamic testing of tissue mechanical property, diabetic foot complications, ulcer genesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 19 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to compare the dynamic response of microcirculation in the skin on the bottom of the big toe after applying controlled plantar stress in 25 diabetic subjects with a history of foot ulcer and 25 age-matched healthy controls to better understand the role of local hypoxia in neuropathic foot ulceration in subjects with diabetes.
The investigators hypothesize that if they apply a gait simulating load to the plantar foot and measure microvascular function, diabetic individuals will demonstrate an increased delay in reestablishing microvascular flow compared to healthy individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic Test | – | –Diabetic individuals with a history of previous plantar ulcer and a high risk of developing a foot ulceration |
| Healthy Controls | – | –Non-diabetic, healthy individuals with low risk of developing a neurogenic foot ulcer |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A community sample
Key inclusion criteria (4 listed)
- between ages 40 and 75
- history of diabetic neuropathic plantar ulcer (test subjects)
- no history of diabetes (control subjects)
- no peripheral sensory neuropathy (control subjects)
Key exclusion criteria (1 listed)
- amputation or surgery on right Great Toe
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Latency time after occlusive loading
Time frame: approximately 2.75 minutes after start of collection protocol
The time between removal of occluding pressure and the initiation of the post-occlusive hyperemic response as measured by laser Doppler.
2 secondary outcomes
Response time to baseline
Time frame: 2.75 seconds after start of collection protocol
Response time to Maximum Flow
Time frame: At least 2.75 seconds after the start of collection protocol.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinsup Song, DPM, PhD study director
Temple University
James A Furmato, DPM, PhD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foot Ulcer, Diabetic, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency time after occlusive loading (time frame: approximately 2.75 minutes after start of collection protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2016.